Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID04985695

Influence of Analgesic Technique on Post Operative Rehabilitation After Median Laparotomy: Comparison Between Thoracic Epidural Anesthesia Versus Bilateral Rectus Sheath Block

Led by Centre Hospitalier Régional Metz-Thionville · Updated on 2025-12-16

110

Participants Needed

2

Research Sites

26 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating two different locoregional anesthesia techniques to manage postoperative pain and aid recovery after a midline laparotomy, a type of abdominal surgery. This randomized controlled trial compares the commonly used epidural analgesia with a newer method called bilateral rectus sheath block. The study aims to understand how these pain relief methods influence patients' quality of recovery after surgery, measured by the Quality of Recovery-15 score. Participants are randomly assigned to one of two groups: one receiving thoracic epidural analgesia, where a catheter is placed in the epidural space to deliver local anesthetic, and the other receiving bilateral rectus sheath block under ultrasound guidance, with anesthetic delivered via catheters on both sides of the abdomen. Both groups undergo the same type of abdominal surgery, and the treatments are part of a multimodal pain management approach during and after surgery. During the study, patients will be monitored for changes in recovery quality on postoperative days 1, 2, and 3, as well as the day before surgery. Assessments include pain control effectiveness, blood pressure effects, nausea, complications related to the analgesic technique, length of hospital stay, bowel function, morphine use, and patient satisfaction up to 30 days after surgery. Catheter placement success, mobility, and other postoperative events are also tracked to understand the impact of each anesthesia method on rehabilitation.

CONDITIONS

Brief Title

Influence of Analgesic Technique on Post Operative Rehabilitation After Median Laparotomy

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults classified as ASA Class I-IV with planned midline laparotomy
  • Have provided written informed consent
  • Able to read and understand French
  • Affiliated with a social security system
Not Eligible

You will not qualify if you...

  • Allergy or contraindication to local anesthetics or epidural analgesia
  • Conditions like porphyria, hemolytic anemia, uncontrolled epilepsy, severe cardiac conduction disorders
  • Coagulation disorders, progressive neurological disease, or severe spinal disorder
  • Inability to place bilateral rectus sheath block
  • Participation in another clinical study
  • Pregnant women
  • Persons deprived of liberty by judicial or administrative decision
  • Patients under psychiatric care as defined by French Public Health Code

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

Duration - Day 0 (surgery day) and immediate post-operative period

Participants undergo a midline laparotomy and receive one of two analgesic techniques: thoracic epidural anesthesia or bilateral rectus sheath block for postoperative pain management.

1 surgery visit and several visits during immediate post-operative care

Post-operative Follow-up

Duration - Up to 30 days after surgery

Participants are monitored for recovery, pain management, complications, and quality of recovery using various assessments up to 30 days after surgery.

Visits on postoperative days 1, 2, 3, at hospital discharge, and day 30

Trial Site Locations

Total: 2 locations

1

CHR Metz Thionville Hopital de Mercy

Metz, Moselle, France, 57085

Actively Recruiting

2

CHR Metz-Thionville Hopital Bel Air

Thionville, France, 57126

Not Yet Recruiting

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Research Team

A

Arpiné EL NAR, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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Published Research Related To This Trial

Effect of rectus sheath anaesthesia versus thoracic epidural analgesia on postoperative recovery quality after elective open abdominal surgery in a French regional hospital: the study protocol of a randomised controlled QoR-RECT-CATH trial.

Thomas Maury, Arpiné Elnar, Sandra Marchionni...

https://pubmed.ncbi.nlm.nih.gov/37221022